Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:37 AM
Ignite Modification Date:
2025-12-25 @ 12:37 AM
NCT ID:
NCT06114667
Eligibility Criteria:
Adult Patient admitted to the ED for acute exacerbation of COPD (AE-COPD)and respiratory acidosis (PaCO2 \> 45 mmHg and pH \<7.35), for whom ventilatory assistance by NIV is indicated (SPLF 2017, GOLD2023 recommendations)
Inclusion Criteria:
* Patients with ability to understand and give an informed consent
* Patients affiliated with or who benefit from a social security
* Patients admitted to the emergency department for a clinical suspicion of AE-COPD based on clinical history, physical examination and chest X-ray (SPLF 2017)
* Patients with acute respiratory failure defined by: Respiratory rate ≥ 25 bpm AND/OR Signs of respiratory failure (use of accessory respiratory muscles, paradoxical abdominal movement)
* Patients with respiratory acidosis defined by PaCO2 \> 45 mmHg AND pH \< 7.35 (measured on arterial blood gas)
Exclusion Criteria:
* Patients who have already received NIV treatment before inclusion (including in-hospital or prehospital, with the exception of NIV at home)
* Contraindication to non-invasive ventilation (SPLF 2017 and GOLD 2023 recommendations)
* Patient uncooperative, agitated, opponent of the technique
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
85 Years
Study:
NCT06114667
Study Brief:
Protocol Section:
NCT06114667